Donavyn Coffey

China’s investigator-initiated trial system is facing international scrutiny after previously undisclosed gene therapy deaths highlighted weak oversight and poor transparency. AstraZeneca and Daiichi Sankyo reported phase 3 successes for Enhertu and the Orpathys-Tagrisso combination in selected non-small cell lung cancer populations, although AstraZeneca’s bispecific volrustomig failed in another phase 3 trial. Biokin Pharma’s iza-bren met its interim primary endpoint, supporting Bristol Myers Squibb’s plans for a global study. Leo Pharma agreed to pay Tanabe Pharma $435 million in upfront and near-term milestones for global rights to dersimelagon, which is awaiting an FDA decision for rare protoporphyria conditions. Sandoz also agreed to a biosimilars collaboration with Shanghai Henlius worth up to $322 million.

NICE has recommended Eli Lilly’s once-weekly insulin injection Onswik for potential NHS coverage in the UK, pending marketing authorization from the MHRA. Evidence from three late-stage QWINT trials found that Onswik achieved non-inferior A1C reduction and similar safety compared with daily insulin, while potentially reducing annual injections by 85% and easing treatment for patients who need assistance. The recommendation comes amid broader tensions between pharmaceutical companies and UK cost-effectiveness rules, though a recent US-UK trade agreement is expected to increase NHS spending on new medicines and raise NICE’s pricing threshold.

The FDA approved Regeneron’s garetosmab, marketed as Pasatru, as the second treatment for fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder in which soft tissue progressively turns to bone. In the phase 3 Optima trial, monthly Pasatru reduced new bone lesions by about 90% and, at the higher dose, cut painful inflammatory flare-ups by 89% versus placebo. The approval follows earlier safety concerns that delayed filing, but the pivotal trial reported no deaths, serious bleeding events or treatment discontinuations among Pasatru recipients. Regeneron expects to make the drug available quickly, provide financial-assistance programs and pursue approvals abroad, while planning a pediatric trial. Its commercial challenge will be reaching a small, underdiagnosed patient population and competing with Ipsen’s Sohonos, whose launch has been hindered by limited uptake, price and side effects.

EyePoint Pharmaceuticals' stock fell more than 70% after Duravyu failed to demonstrate non-inferiority to Regeneron's Eylea on a primary visual-acuity endpoint in a phase 3 wet age-related macular degeneration trial. EyePoint attributed the result partly to unusual non-disease-related vision loss among nine Duravyu patients and said an ad hoc analysis excluding those cases met the non-inferiority threshold. Duravyu nevertheless reduced injection frequency by 42% and showed a favorable safety profile, leading some analysts to argue that a positive result from the company’s second phase 3 trial, Lucia, could preserve its approval prospects. The setback increases uncertainty around Duravyu while benefiting competitor Ocular Therapeutix.

K2 Therapeutics has appointed former Legend Biotech CEO Ying Huang to lead the startup, which has offices in Singapore and Boston and eight drug candidates across antibody-drug conjugate and T-cell engager programs. The roundup also covers leadership changes at Tanai Therapeutics, Bicara Therapeutics, Acelot, Flagship Pioneering, Erasca, City Therapeutics, the Quantitative Biosciences Institute, Kailera Therapeutics and Chinilabs. Bicara founder Claire Mazumdar will become vice chair and strategic adviser as Ryan Cohlhepp takes over ahead of interim results from the Phase 2/3 FORTIFI-HN01 trial of ficerafusp alfa.

Alfasigma plans to acquire Nordic Pharma from Sever Life Sciences for an undisclosed sum, subject to regulatory and other closing conditions, with completion expected by the end of 2026. The deal would add Nordic’s rheumatology, women’s health, critical care and ophthalmology portfolios—including the methotrexate injection Nordimet—and expand Alfasigma’s commercial reach into Japan and Canada while strengthening its European and U.S. presence. The acquisition continues Alfasigma’s strategy of using targeted deals and licensing agreements to grow its specialty, immunology and rare-disease businesses. Its rheumatology drug Jyseleca delivered double-digit growth in 2025, while the company seeks European approval for an axial spondyloarthritis indication.